Tuyory
Tocilizumab biosimilar developed by Gedeon Richter, development code RGB-19. Reference product Actemra (RoActemra in the European Union).
Brands by market: Tuyory (EU) · Commercial partner or holder: Gedeon Richter · Company profile
FDANot listed
EMAApr 2026authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 2 of 7 markets
Connections
About Tuyory
Tuyory is Gedeon Richter's tocilizumab, approved in Europe in April 2026, the fourth tocilizumab biosimilar there. Richter has not named the developer.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Tuyory
European Medicines Agency and European CommissionApprovedBrand
Tuyory
Holder or applicant
Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)
Pathway
Centralised (Article 10(4))
Approved
Apr 2026
Application or permission
EMEA/H/C/006416
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Tuyory
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Tuyory
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
162 mg syringe and pen; 20 mg/mL concentrate
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Tuyory holds an approval, these are the other tocilizumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| EMA | 3 | Bio-Thera Solutions (Tofidence / Tocilizumab STADA), Celltrion (Avtozma), Fresenius Kabi (Tyenne) |
| MHRA | 3 | Bio-Thera Solutions (Tofidence / Tocilizumab STADA), Celltrion (Avtozma), Fresenius Kabi (Tyenne) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Gedeon Richter: Enoby / Xtrenbo / Junod / Yaxwer, Terrosa / Movymia, Usymro.
Chronology
- EMAApr 2026Authorised by the European Commission as Tuyory
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
Planning tocilizumab biosimilar development?
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Talk to a biosimilar regulatory consultantData current to September 2026.